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A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 5, 2009
Last updated: January 21, 2010
Last verified: January 2010
PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.

Condition Intervention Phase
Asthma Drug: PF-03893787 Drug: Placebo Drug: Montelukast Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Spirometry pre- and post- bronchial allergen challenge [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Laboratory safety tests [ Time Frame: 2 months ]
  • 12-lead ECGs [ Time Frame: 2 months ]
  • Adverse Event reporting [ Time Frame: 2 months ]
  • Blood samples for pharmacokinetic measurement [ Time Frame: 2 months ]

Estimated Enrollment: 12
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-03893787 Drug: PF-03893787
Oral, two doses 12 hours apart
Placebo Comparator: Placebo Drug: Placebo
Oral, two doses 12 hours apart
Active Comparator: Montelukast Drug: Montelukast
Oral, two doses 12 hours apart


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females 18-60 years.
  • Mild asthma
  • Atopic to allergens

Exclusion Criteria:

  • Unstable asthma.
  • Smokers or recent ex-smokers
  • Recent allergen challenge
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00856687

United Kingdom
Pfizer Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00856687     History of Changes
Other Study ID Numbers: B0281002
Study First Received: March 5, 2009
Last Updated: January 21, 2010

Keywords provided by Pfizer:
Asthma Allergen Challenge

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017